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2016/10/102016IpcaLaboratoriesLimited1/29/16
IpcaLaboratoriesLimited1/29/16
DepartmentofHealthandHumanServices
PublicHealthService
FoodandDrugAdministration
SilverSpring,MD20993
WarningLetter
ViaUPS
WL:320-16-07
January29,2016
Mr.PremchandGodha
ChairmanManagingDirector
IpcaLaboratoriesLtd.
48,KandivliIndustrialEstate
Kandivli(West),Mumbai400067
India
DearMr.Godha:
In2014,theU.S.FoodandDrugAdministration(FDA)inspectedthreeIpcapharmaceutical
manufacturingfacilities.
A.July14–18:P.O.No.33VillageSejavata,Ratlam457002MadhyaPradesh(Ratlamfacility)
B.October13–17:1PharmaZone,SEZPhaseII,Sector3,DistrictDhar,Pithampur,Madhya
Pradesh(Pithampurfacility)
C.December1–19:Plot6599,DanudyogIndustrialEstate,PipariaSilvassa396230(Union
TerritoryofDadraNagarHaveli)(PipariaSilvassafacility)
/ICECI/EnforcementActions/WarningLetters/2016/ucm484910.htm1/10
2016/10/102016IpcaLaboratoriesLimited1/29/16
AtyourRatlamfacility,weidentifiedsignificantdeviationsfromcurrentgoodmanufacturing
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